INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODE

Fabricante

  • Dirección del fabricante
    BRAMPTON
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC

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    Medical electronics / Electromedical devices - electrotherapy
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    Medical Device Safety Alert: Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes
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  • Descripción del producto
    Infant/Child Reduced Energy Defibrillation Electrodes, Physio-Control
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    Model Catalog: 3202784-009 (Lot serial: 45932237); Model Catalog: 3202380-006 (Lot serial: 713609); Model Catalog: 3202784-009 (Lot serial: 718033); Model Catalog: 3202380-006 (Lot serial: 718033); Model Catalog: 3202784-009 (Lot serial: 717912); Model Catalog: 3202380-006 (Lot serial: 717912); Model Catalog: 3202784-009 (Lot serial: 715008); Model Catalog: 3202380-006 (Lot serial: 715008); Model Catalog: 3202784-009 (Lot serial: 713904); Model Catalog: 3202380-006 (Lot serial: 713904); Model Catalog: 3202784-009 (Lot serial: 713609); Model Catalog: 3202380-006 (Lot serial: 45979590); Model Catalog: 3202784-009 (Lot serial: 45979590); Model Catalog: 3202380-006 (Lot serial: 46061770); Model Catalog: 3202784-009 (Lot serial: 46061770); Model Catalog: 3202380-006 (Lot serial: 45932237)
  • Descripción del producto
    INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODE
  • Manufacturer